Cleared Traditional

Konan Specular Microscope XVII

K191558 · Konan Medical, Inc. · Ophthalmic

Mar 2020

Decision

288d

Days

Class 2

Risk

About This 510(k) Submission

K191558 is an FDA 510(k) clearance for the Konan Specular Microscope XVII, a Microscope, Specular (Class II — Special Controls, product code NQE), submitted by Konan Medical, Inc. (Nishinomiya, JP). The FDA issued a Cleared decision on March 26, 2020, 288 days after receiving the submission on June 12, 2019. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1850.

Submission Details

510(k) Number	K191558 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 12, 2019
Decision Date	March 26, 2020
Days to Decision	288 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF

Device Classification

Product Code	NQE — Microscope, Specular
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 886.1850
Definition	Specular Microscopes Are Used For The Microscopic Imaging And Assessment Of The Corneal Endothelial Cell Layer In Vivo Or In Vitro.